Intra-thoracic collateral ventilation bypass system

ABSTRACT

A long term oxygen therapy system having an oxygen supply directly linked with a patient&#39;s lung or lungs may be utilized to more efficiently treat hypoxia caused by chronic obstructive pulmonary disease such as emphysema and chronic bronchitis. The system includes an oxygen source, one or more valves and fluid carrying conduits. The fluid carrying conduits link the oxygen source to diseased sites within the patient&#39;s lungs. A collateral ventilation bypass trap system directly linked with a patient&#39;s lung or lungs may be utilized to increase the expiratory flow from the diseased lung or lungs, thereby treating another aspect of chronic obstructive pulmonary disease. The system includes a trap, a filter/one-way valve and an air carrying conduit. In various embodiments, the system may be intrathoracic, extrathoracic or a combination thereof. A pulmonary decompression device may also be utilized to remove trapped air in the lung or lungs, thereby reducing the volume of diseased lung tissue. A lung reduction device may passively decompress the lung or lungs. In order for the system to be effective, an airtight seal between the parietal and visceral pleurae is required. Chemical pleurodesis is utilized for creating the seal.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of Provisional ApplicationNo. 60/475,990 filed Jun. 5, 2003.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to systems and methods for removingtrapped air in emphysematous lungs, and more particularly, to systemsand methods for removing trapped air in emphysematous hyperinflatedlungs by bypassing non-patent airways via a conduit through the outerpleural layer of the lung to a containment/trap device. The presentinvention also relates to a collateral ventilation bypass system thatutilizes the trachea for expelling trapped air rather than acontainment/trap device. The present invention also relates to a deviceand methodology to assist in pulmonary decompression andnon-surgical/resection lung volume reduction. The present invention alsorelates to systems and methods for chemical pleurodesis.

[0004] 2. Discussion of the Related Art

[0005] As a result of studies that date back to the 1930's andparticularly studies conducted in the 1960's and early 1970's, it hasbeen determined that long-term continuous oxygen therapy is beneficialin the treatment of hypoxemic patients with chronic obstructivepulmonary disease. In other words, a patient's life and quality of lifecan be improved by providing a constant supplemental supply of oxygen tothe patient's lungs.

[0006] However, with the desire to contain medical costs, there is agrowing concern that the additional cost of providing continuous oxygentherapy for chronic lung disease will create an excessive increase inthe annual cost of oxygen therapy. Thus, it is desirable that oxygentherapy, when provided, be as cost effective as possible.

[0007] The standard treatment for patients requiring supplemental oxygenis still to deliver oxygen from an oxygen source by means of a nasalcannula. Such treatment, however, requires a large amount of oxygen,which is wasteful and can cause soreness and irritation to the nose, aswell as being potentially aggravating. Other undesirable effects havealso been reported. Various other medical approaches which have beenproposed to help reduce the cost of continuous oxygen therapy have beenstudied.

[0008] Various devices and methods have been devised for performingemergency cricothyroidotomies and for providing a tracheotomy tube sothat a patient whose airway is otherwise blocked may continue to breath.Such devices are generally intended only for use with a patient who isnot breathing spontaneously and are not suitable for the long termtreatment of chronic lung disease. Typically, such devices are installedby puncturing the skin to create a hole into the cricoid membrane of thelarynx above the trachea into which a relatively large curvedtracheotomy tube is inserted. As previously described, the use of suchtubes has been restricted medically to emergency situations where thepatient would otherwise suffocate due to the blockage of the airway.Such emergency tracheotomy tubes are not suitable for long term therapyafter the airway blockage is removed.

[0009] Other devices which have been found satisfactory for emergency orventilator use are described in U.S. Pat. No. 953,922 to Rogers; U.S.Pat. No. 2,873,742 to Shelden; U.S. Pat. No. 3,384,087 to Brummelkamp;U.S. Pat. No. 3,511,243 to Toy; U.S. Pat. No. 3,556,103 to Calhoun; U.S.Pat. No. 2,991,787 to Shelden, et al; U.S. Pat. No. 3,688,773 to Weiss;U.S. Pat. No. 3,817,250 to Weiss, et al.; and U.S. Pat. No. 3,916,903 toPozzi.

[0010] Although tracheotomy tubes are satisfactory for their intendedpurpose, they are not intended for chronic usage by outpatients as ameans for delivering supplemental oxygen to spontaneously breathingpatients with chronic obstructive pulmonary disease. Such tracheotomytubes are generally designed so as to provide the total air supply tothe patient for a relatively short period of time. The tracheotomy tubesare generally of rigid or semi-rigid construction and of caliber rangingfrom 2.5 mm outside diameter in infants to 15 mm outside diameter inadults. They are normally inserted in an operating room as a surgicalprocedure or during emergency situations, through the crico-thyroidmembrane where the tissue is less vascular and the possibility ofbleeding is reduced. These devices are intended to permit passage of airin both directions until normal breathing has been restored by othermeans.

[0011] Another type of tracheotomy tube is disclosed in Jacobs, U.S.Pat. Nos. 3,682,166 and 3,788,326. The catheter described therein isplaced over 14 or 16 gauge needle and inserted through the crico-thyroidmembrane for supplying air or oxygen and vacuum on an emergency basis torestore the breathing of a non-breathing patient. The air or oxygen issupplied at 30 to 100 psi for inflation and deflation of the patient'slungs. The Jacobs catheter, like the other tracheotomy tubes previouslyused, is not suitable for long term outpatient use, and could not easilybe adapted to such use.

[0012] Due to the limited functionality of tracheotomy tubes,transtracheal catheters have been proposed and used for long termsupplemental oxygen therapy. For example the small diametertranstracheal catheter (16 gauge) developed by Dr. Henry J. Heimlich(described in THE ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY,November-December 1982; Respiratory Rehabilitation with TranstrachealOxygen System) has been used by the insertion of a relatively largecutting needle (14 gauge) into the trachea at the mid-point between thecricothyroid membrane and the sternal notch. This catheter size cansupply oxygen up to about 3 liters per minute at low pressures, such as2 psi which may be insufficient for patients who require higher flowrates. It does not, however, lend itself to outpatient use andmaintenance, such as periodic removal and cleaning, primarily becausethe connector between the catheter and the oxygen supply hose isadjacent and against the anterior portion of the trachea and cannot beeasily seen and manipulated by the patient. Furthermore, the catheter isnot provided with positive means to protect against kinking orcollapsing which would prevent its effective use on an outpatient basis.Such a feature is not only desirable but necessary for long termoutpatient and home care use. Also, because of its structure, i.e. onlyone exit opening, the oxygen from the catheter is directed straight downthe trachea toward the bifurcation between the bronchi. Because of thenormal anatomy of the bronchi wherein the left bronchus is at a moreacute angle to the trachea than the right bronchus, more of the oxygenfrom that catheter tends to be directed into the right bronchus ratherthan being directed or mixed for more equal utilization by both bronchi.Also, as structured, the oxygen can strike the carina, resulting in anundesirable tickling sensation and cough. In addition, in such devices,if a substantial portion of the oxygen is directed against the back wallof the trachea causing erosion of the mucosa in this area which maycause chapping and bleeding. Overall, because of the limited output fromthe device, it may not operate to supply sufficient supplemental oxygenwhen the patient is exercising or otherwise quite active or has severedisease.

[0013] Diseases associated with chronic obstructive pulmonary diseaseinclude chronic bronchitis and emphysema. One aspect of an emphysematouslung is that the communicating flow of air between neighboring air sacsis much more prevalent as compared to healthy lungs. This phenomenon isknown as collateral ventilation. Another aspect of an emphysematous lungis that air cannot be expelled from the native airways due to the lossof tissue elastic recoil and radial support of the airways. Essentially,the loss of elastic recoil of the lung tissue contributes to theinability of individuals to exhale completely. The loss of radialsupport of the airways also allows a collapsing phenomenon to occurduring the expiratory phase of breathing. This collapsing phenomenonalso intensifies the inability for individuals to exhale completely. Asthe inability to exhale completely increases, residual volume in thelungs also increases. This then causes the lung to establish in ahyperinflated state where an individual can only take short shallowbreaths. Essentially, air is not effectively expelled and stale airaccumulates in the lungs. Once the stale air accumulates in the lungs,the individual is deprived of oxygen.

[0014] Currently, treatments for chronic obstructive pulmonary diseaseinclude bronchodilating drugs, oxygen therapy as described above, andlung volume reduction surgery. Bronchodilating drugs only work on apercentage of patients with chronic obstructive pulmonary disease andgenerally only provides short term relief. Oxygen therapy is impracticalfor the reasons described above, and lung volume reduction surgery is anextremely traumatic procedure that involves removing part of the lung.The long term benefits of lung volume reduction surgery are not fullyknown.

[0015] Accordingly, there exists a need for increasing the expiratoryflow from an individual suffering from chronic obstructive pulmonarydisease. In addition, there exists a need for a minimally invasive meansfor removing trapped air from the lung or lungs that would allow healthylung tissue to better ventilate. There also exists a need for aminimally invasive means for allowing trapped air from the lung or lungsto escape that would allow healthy lung tissue to better ventilate.

SUMMARY OF THE INVENTION

[0016] The present invention overcomes the disadvantages associated withtreating chronic obstructive pulmonary disease, as briefly describedabove, by utilizing the phenomenon of collateral ventilation to increasethe expiratory flow from a diseased lung. The present invention alsoprovides a means for assisting in or facilitating pulmonarydecompression to compress the diseased area or area of the lung or lungsto a smaller volume.

[0017] The intra-thoracic collateral ventilation bypass system of thepresent invention removes trapped air in an emphysematous hyperinflatedlung by bypassing non-patent airways via a conduit through the outerpleural layer of the lung to a more proximal airway closer to thetrachea.

[0018] In accordance with a first aspect, the present invention isdirected to an intra-thoracic collateral ventilation bypass system. Thesystem comprising at least one conduit having first and second ends, afirst sealing device and a second sealing device. The first end of theconduit is in fluid communication with an airway in proximity to atrachea of a patient and the second end is in fluid communication withthe inner volume of a lung of a patient at a predetermined site. Thefirst sealing device is utilized for establishing an airtight sealbetween the conduit and the proximate airway. The second sealing deviceis utilized for establishing an airtight seal between the conduit andthe lung.

[0019] In accordance with another aspect, the present invention isdirected to a method for decompressing a hyperinflated portion of a lungof a patient. The method comprising determining a site of hyperinflationin a patient's lung, and bypassing non-patent airways utilizing a devicein communication with a hyperinflated portion of a patient's lung and anairway proximate a patient's trachea.

[0020] The long-term oxygen therapy system of the present inventiondelivers oxygen directly to diseased sites in a patient's lungs. Longterm oxygen therapy is widely accepted as the standard treatment forhypoxia caused by chronic obstructive pulmonary disease, for example,pulmonary emphysema. Pulmonary emphysema is a chronic obstructivepulmonary disease wherein the alveoli of the lungs lose their elasticityand the walls between adjacent alveoli are destroyed. As more and morealveoli walls are lost, the air exchange surface area of the lungs isreduced until air exchange becomes seriously impaired. The combinationof mucus hypersecretion and dynamic air compression is a mechanism ofairflow limitation in chronic obstructive pulmonary disease. Dynamic aircompression results from the loss of tethering forces exerted on theairway due to the reduction in lung tissue elasticity. Essentially,stale air accumulates in the lungs, thereby depriving the individual ofoxygen. Various methods may be utilized to determine the location orlocations of the diseased tissue, for example, computerized axialtomography or CAT scans, magnetic resonance imaging or MRI, positronemission tomograph or PET, and/or standard X-ray imaging. Once thelocation or locations of the diseased tissue are located, anastomoticopenings are made in the thoracic cavity and lung or lungs and one ormore oxygen carrying conduits are positioned and sealed therein. The oneor more oxygen carrying conduits are connected to an oxygen source whichsupplies oxygen under elevated pressure directly to the diseased portionor portions of the lung or lungs. The pressurized oxygen essentiallydisplaces the accumulated air and is thus more easily absorbed by thealveoli tissue. In addition, the long term oxygen therapy system may beconfigured in such a way as to provide collateral ventilation bypass inaddition to direct oxygen therapy. In this configuration, an additionalconduit may be connected between the main conduit and the individual'strachea with the appropriate valve arrangement. In this configuration,stale air may be removed through the trachea when the individual exhalessince the trachea is directly linked with the diseased site or sites inthe lung via the conduits.

[0021] The long term oxygen therapy system of the present inventionimproves oxygen transfer efficiency in the lungs thereby reducing oxygensupply requirements, which in turn reduces the patient's medical costs.The system also allows for improved self-image, improved mobility,greater exercise capability and is easily maintained.

[0022] The above-described long term oxygen therapy system may beutilized to effectively treat hypoxia caused by chronic obstructivepulmonary disease; however, other means may be desirable to treat otheraspects of the disease. As set forth above, emphysema is distinguishedas irreversible damage to lung tissue. The breakdown of lung tissueleads to the reduced ability for the lungs to recoil. The tissuebreakdown also leads to the loss of radial support of the airways.Consequently, the loss of elastic recoil of the lung tissue contributesto the inability for individuals with emphysema to exhale completely.The loss of radial support of the airways also allows a collapsingphenomenon to occur during the expiratory phase of breathing. Thiscollapsing phenomenon also intensifies the inability for individuals toexhale completely. As the inability to exhale increases, residual volumein the lungs also increases. This then causes the lung to establish in ahyperinflated state wherein an individual can only take short shallowbreaths.

[0023] The collateral ventilation bypass trap system of the presentinvention utilizes the above-described collateral ventilation phenomenonto increase the expiratory flow from a diseased lung or lungs, therebytreating another aspect of chronic obstructive pulmonary disease.Essentially, the most collaterally ventilated area of the lung or lungsis determined utilizing the scanning techniques described above. Oncethis area or areas are located, a conduit or conduits are positioned ina passage or passages that access the outer pleural layer of thediseased lung or lungs. The conduit or conduits utilize the collateralventilation of the lung or lungs and allow the entrapped air to bypassthe native airways and be expelled to a containment system outside ofthe body.

[0024] In an alternate embodiment, the trachea, or other proximalairways, including the bronchus, may be utilized for expelling trappedair rather than a containment/trap device.

[0025] The pulmonary decompression device of the present inventionremoves air from hyperinflated regions of the lung or lungs of a patientby creating a slight pressure differential between the internal volumeof the lung and a location external of the lung. An apparatus such as avacuum fan or pump creates the pressure differential, thereby removingthe trapped air and reducing the volume of diseased tissue.

[0026] The lung reduction device of the present invention allows trappedair from hyperinflated regions of the lung or lungs of a patient to ventto the external environment through a one-way valve. The valve preventsair from flowing back into the lung or lungs.

[0027] In order for the system to be effective, the components of thesystem are preferably sealed to the lung. Accordingly, the localizedpleurodesis chemical delivery system of the present invention isutilized to create a pleurodesis in the area or areas of the lung thatare most collaterally ventilated. Various chemicals, agents and/orcompounds may be delivered via catheter based delivery systems or viaimplantable medical devices.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The foregoing and other features and advantages of the inventionwill be apparent from the following, more particular description ofpreferred embodiments of the invention, as illustrated in theaccompanying drawings.

[0029]FIG. 1 is a diagrammatic representation of a first exemplaryembodiment of the long term oxygen therapy system in accordance with thepresent invention.

[0030]FIG. 2 is a diagrammatic representation of a first exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0031]FIG. 3 is a diagrammatic representation of a second exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0032]FIG. 4 is a diagrammatic representation of a third exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0033]FIG. 5 is a diagrammatic representation of a fourth exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0034]FIG. 6 is a diagrammatic representation of a second exemplaryembodiment of the long term oxygen therapy system in accordance with thepresent invention.

[0035]FIG. 7 is a diagrammatic representation of a first exemplaryembodiment of a collateral ventilation bypass trap system in accordancewith the present invention.

[0036]FIG. 8 is a diagrammatic representation of a second exemplaryembodiment of a collateral ventilation bypass system in accordance withthe present invention.

[0037]FIG. 9 is a diagrammatic representation of a third exemplaryembodiment of a collateral ventilation bypass system in accordance withthe present invention.

[0038]FIG. 10 is a diagrammatic representation of a fourth exemplaryembodiment of a collateral ventilation bypass system in accordance withthe present invention.

[0039]FIG. 11 is a diagrammatic representation of an exemplaryembodiment of an intra-thoracic collateral ventilation bypass system inaccordance with the present invention.

[0040]FIG. 12 is a diagrammatic representation of an exemplary pulmonarydecompression device in accordance with the present invention.

[0041]FIGS. 13a and 13 b are diagrammatic representations of the effectson lung volume in accordance with the present invention.

[0042]FIGS. 14a and 14 b are diagrammatic representations of the effectson lung volume reduction utilizing the lung reduction system inaccordance with the present invention.

[0043]FIG. 15 is a diagrammatic representation of a first exemplaryembodiment of a localized pleurodesis chemical delivery system.

[0044]FIG. 16 is a diagrammatic representation of a second exemplaryembodiment of a localized pleurodesis chemical delivery system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] Air typically enters the mammalian body through the nostrils andflows into the nasal cavities. As the air passes through the nostrilsand nasal cavities, it is filtered, moistened and raised or lowered toapproximately body temperature. The back of the nasal cavities iscontinuous with the pharynx (throat region); therefore, air may reachthe pharynx from the nasal cavities or from the mouth. Accordingly, ifequipped, the mammal may breath through its nose or mouth. Generally airfrom the mouth is not as filtered or temperature regulated as air fromthe nostrils. The air in the pharynx flows from an opening in the floorof the pharynx and into the larynx (voice box). The epiglottisautomatically closes off the larynx during swallowing so that solidsand/or liquids enter the esophagus rather than the lower air passagewaysor airways. From the larynx, the air passes into the trachea, whichdivides into two branches, referred to as the bronchi. The bronchi areconnected to the lungs.

[0046] The lungs are large, paired, spongy, elastic organs, which arepositioned in the thoracic cavity. The lungs are in contact with thewalls of the thoracic cavity. In humans, the right lung comprises threelobes and the left lung comprises two lobes. Lungs are paired in allmammals, but the number of lobes or sections of lungs varies from mammalto mammal. Healthy lungs, as discussed below, have a tremendous surfacearea for gas/air exchange. Both the left and right lung is covered witha pleural membrane. Essentially, the pleural membrane around each lungforms a continuous sac that encloses the lung. A pleural membrane alsoforms a lining for the thoracic cavity. The space between the pleuralmembrane forming the lining of the thoracic cavity and the pleuralmembranes enclosing the lungs is referred to as the pleural cavity. Thepleural cavity comprises a film of fluid that serves as a lubricantbetween the lungs and the chest wall.

[0047] In the lungs, the bronchi branch into a multiplicity of smallervessels referred to as bronchioles. Typically, there are more than onemillion bronchioles in each lung. Each bronchiole ends in a cluster ofextremely small air sacs referred to as alveoli. An extremely thin,single layer of epithelial cells lining each alveolus wall and anextremely thin, single layer of epithelial cells lining the capillarywalls separate the air/gas in the alveolus from the blood. Oxygenmolecules in higher concentration pass by simple diffusion through thetwo thin layers from the alveoli into the blood in the pulmonarycapillaries. Simultaneously, carbon dioxide molecules in higherconcentration pass by simple diffusion through the two thin layers fromthe blood in the pulmonary capillaries into the alveoli.

[0048] Breathing is a mechanical process involving inspiration andexpiration. The thoracic cavity is normally a closed system and aircannot enter or leave the lungs except through the trachea. If the chestwall is somehow compromised and air/gas enters the pleural cavity, thelungs will typically collapse. When the volume of the thoracic cavity isincreased by the contraction of the diaphragm, the volume of the lungsis also increased. As the volume of the lungs increase, the pressure ofthe air in the lungs falls slightly below the pressure of the airexternal to the body (ambient air pressure). Accordingly, as a result ofthis slight pressure differential, external or ambient air flows throughthe respiratory passageways described above and fills the lungs untilthe pressure equalizes. This process is inspiration. When the diaphragmis relaxed, the volume of the thoracic cavity decreases, which in turndecreases the volume of the lungs. As the volume of the lungs decrease,the pressure of the air in the lungs rises slightly above the pressureof the air external to the body. Accordingly, as a result of this slightpressure differential, the air in the alveoli is expelled through therespiratory passageways until the pressure equalizes. This process isexpiration.

[0049] Continued insult to the respiratory system may result in variousdiseases, for example, chronic obstructive pulmonary disease. Chronicobstructive pulmonary disease is a persistent obstruction of the airwayscaused by chronic bronchitis and pulmonary emphysema. In the UnitedStates alone, approximately fourteen million people suffer from someform of chronic obstructive pulmonary disease and it is in the top tenleading causes of death.

[0050] Chronic bronchitis and acute bronchitis share certain similarcharacteristics; however, they are distinct diseases. Both chronic andacute bronchitis involve inflammation and constriction of the bronchialtubes and the bronchioles; however, acute bronchitis is generallyassociated with a viral and/or bacterial infection and its duration istypically much shorter than chronic bronchitis. In chronic bronchitis,the bronchial tubes secrete too much mucus as part of the body'sdefensive mechanisms to inhaled foreign substances. Mucus membranescomprising ciliated cells (hair like structures) line the trachea andbronchi. The ciliated cells or cilia continuously push or sweep themucus secreted from the mucus membranes in a direction away from thelungs and into the pharynx, where it is periodically swallowed. Thissweeping action of the cilia functions to keep foreign matter fromreaching the lungs. Foreign matter that is not filtered by the nose andlarynx, as described above, becomes trapped in the mucus and ispropelled by the cilia into the pharynx. When too much mucus issecreted, the ciliated cells may become damaged, leading to a decreasein the efficiency of the cilia to sweep the bronchial tubes and tracheaof the mucus containing the foreign matter. This in turn causes thebronchioles to become constricted and inflamed and the individualbecomes short of breath. In addition, the individual will develop achronic cough as a means of attempting to clear the airways of excessmucus.

[0051] Individuals who suffer from chronic bronchitis may developpulmonary emphysema. Pulmonary emphysema is a disease in which thealveoli walls, which are normally fairly rigid structures, aredestroyed. The destruction of the alveoli walls is irreversible.Pulmonary emphysema may be caused by a number of factors, includingchronic bronchitis, long term exposure to inhaled irritants, e.g. airpollution, which damage the cilia, enzyme deficiencies and otherpathological conditions. In pulmonary emphysema, the alveoli of thelungs lose their elasticity, and eventually the walls between adjacentalveoli are destroyed. Accordingly, as more and more alveoli walls arelost, the air exchange (oxygen and carbon dioxide) surface area of thelungs is reduced until air exchange becomes seriously impaired. Thecombination of mucus hypersecretion and dynamic airway compression aremechanisms of airflow limitation in chronic obstructive pulmonarydisease. Dynamic airway compression results from the loss of tetheringforces exerted on the airway due to the reduction in lung tissueelasticity. Mucus hypersecretion is described above with respect tobronchitis. In other words, the breakdown of lung tissue leads to thereduced ability of the lungs to recoil and the loss of radial support ofthe airways. Consequently, the loss of elastic recoil of the lung tissuecontributes to the inability of individuals to exhale completely. Theloss of radial support of the airways also allows a collapsingphenomenon to occur during the expiratory phase of breathing. Thiscollapsing phenomenon also intensifies the inability for individuals toexhale completely. As the inability to exhale completely increases,residual volume in the lungs also increases. This then causes the lungto establish in a hyperinflated state where an individual can only takeshort shallow breaths. Essentially, air is not effectively expelled andstale air accumulates in the lungs. Once the stale air accumulates inthe lungs, the individual is deprived of oxygen. There is no cure forpulmonary emphysema, only various treatments, including exercise, drugtherapy, such as bronchodilating agents, lung volume reduction surgeryand long term oxygen therapy.

[0052] As described above, long term oxygen therapy is widely acceptedas the standard treatment for hypoxia caused by chronic obstructivepulmonary disease. Typically, oxygen therapy is prescribed using a nasalcannula. There are disadvantages associated with using the nasalcannula. One disadvantage associated with utilizing nasal cannula is thesignificant loss of oxygen between the cannula and the nose, which inturn equates to more frequent changes in the oxygen source, or higherenergy requirements to generate more oxygen. Another disadvantageassociated with utilizing nasal cannula is the fact that the cannulasmay cause the nasal passages to become dry, cracked and sore.

[0053] Transtracheal oxygen therapy has become a viable alternative tolong term oxygen therapy. Transtracheal oxygen therapy delivers oxygendirectly to the lungs using a catheter that is placed through and downthe trachea. Due to the direct nature of the oxygen delivery, a numberof advantages are achieved. These advantages include lower oxygenrequirements due to greater efficiency, increased mobility, greaterexercise capability and improved self image.

[0054] The long term oxygen therapy system and method of the presentinvention may be utilized to deliver oxygen directly into the lungtissue in order to optimize oxygen transfer efficiency in the lungs. Inother words, improved efficiency may be achieved if oxygen were to bedelivered directly into the alveolar tissue in the lungs. In emphysema,alveoli walls are destroyed, thereby causing a decrease in air exchangesurface area. As more alveoli walls are destroyed, collateralventilation resistance is lowered. In other words, pulmonary emphysemacauses an increase in collateral ventilation and to a certain extent,chronic bronchitis also causes an increase in collateral ventilation.Essentially, in an emphysematous lung, the communicating flow of airbetween neighboring air sacs (alveoli), known as collateral ventilation,is much more prevalent as compared to a normal lung. Since air cannot beexpelled from the native airways due to the loss of tissue elasticrecoil and radial support of the airways (dynamic collapse duringexhalation), the increase in collateral ventilation does notsignificantly assist an individual in breathing. The individual developsdsypnea. Accordingly, if it can be determined where collateralventilation is occurring, then the diseased lung tissue may be isolatedand the oxygen delivered to this precise location or locations. Variousmethods may be utilized to determine the diseased tissue locations, forexample, computerized axial tomography or CAT scans, magnetic resonanceimaging or MRI, positron emission tomograph or PET, and/or standardX-ray imaging. Once the diseased tissue is located, pressurized oxygenmay be directly delivered to these diseased areas and more effectivelyand efficiently forced into the lung tissue for air exchange.

[0055]FIG. 1 illustrates a first exemplary long term oxygen therapysystem 100. The system 100 comprises an oxygen source 102, an oxygencarrying conduit 104 and a one-way valve 106. The oxygen source 102 maycomprise any suitable device for supplying filtered oxygen underadjustably regulated pressures and flow rates, including pressurizedoxygen tanks, liquid oxygen reservoirs, oxygen concentrators and theassociated devices for controlling pressure and flow rate e.g.regulators. The oxygen carrying conduit 104 may comprise any suitablebiocompatible tubing having a high resistance to damage caused bycontinuous oxygen exposure. The oxygen carrying conduit 104 comprisestubing having an inside diameter in the range from about {fraction(1/16)} inch to about ½ inch and more preferably from about ⅛ inch toabout ¼ inch. The one-way valve 106 may comprise any suitable, in-linemechanical valve which allows oxygen to flow into the lungs 108 throughthe oxygen carrying conduit 104, but not from the lungs 108 back intothe oxygen source 102. For example, a simple check valve may beutilized. As illustrated in FIG. 1, the oxygen carrying conduit 104passes through the lung 108 at the site determined to have the highestdegree of collateral ventilation.

[0056] The exemplary system 100 described above may be modified in anumber of ways, including the use of an in-line filter. In thisexemplary embodiment, both oxygen and air may flow through the system.In other words, during inhalation, oxygen is delivered to the lungsthrough the oxygen carrying conduit 104 and during exhalation, air fromthe lungs flow through the oxygen carrying conduit 104. The in-linefilter would trap mucus and other contaminants, thereby preventing ablockage in the oxygen source 102. In this exemplary embodiment, novalve 106 would be utilized. The flow of oxygen into the lungs and theflow of air from the lungs is based on pressure differentials.

[0057] In order for the exemplary long term oxygen therapy system 100 tofunction, an airtight seal is preferably maintained where the oxygencarrying conduit 104 passes through the thoracic cavity and lung. Thisseal is maintained in order to sustain the inflation/functionality ofthe lungs. If the seal is breached, air can enter the cavity and causethe lungs to collapse as described above.

[0058] A method to create this seal comprises forming adhesions betweenthe visceral pleura of the lung and the inner wall of the thoraciccavity. This may be achieved using either chemical methods, includingirritants such as Doxycycline and/or Bleomycin, surgical methods,including pleurectomy or horoscope talc pleurodesis, or radiotherapymethods, including radioactive gold or external radiation. All of thesemethods are known in the relevant art for creating pleurodesis. With aseal created at the site for the ventilation bypass, an intervention maybe safely performed without the danger of creating a pneumothorax of thelung.

[0059] Similarly to ostomy pouches or bags, the oxygen carrying conduit104 may be sealed to the skin at the site of the ventilation bypass. Inone exemplary embodiment, illustrated in FIG. 2, the oxygen carryingconduit 104 may be sealed to the skin of the thoracic wall utilizing anadhesive. As illustrated, the oxygen carrying conduit 104 comprises aflange 200 having a biocompatible adhesive coating on the skincontacting surface. The biocompatible adhesive would provide a fluidtight seal between the flange 200 and the skin or epidermis of thethoracic wall. In a preferred embodiment, the biocompatible adhesiveprovides a temporary fluid tight seal such that the oxygen carryingconduit 104 may be disconnected from the ventilation bypass site. Thiswould allow for the site to be cleaned and for the long term oxygentherapy system 100 to undergo periodic maintenance.

[0060]FIG. 3 illustrates another exemplary embodiment for sealing theoxygen carrying conduit 104 to the skin of the thoracic wall at the siteof the ventilation bypass. In this exemplary embodiment, a couplingplate 300 is sealed to the skin at the site of the ventilation bypass bya biocompatible adhesive coating or any other suitable means. The oxygencarrying conduit 104 is then connected to the coupling plate 300 by anysuitable means, including threaded couplings and locking rings. Theexemplary embodiment also allows for cleaning of the site andmaintenance of the system 100.

[0061]FIG. 4 illustrates yet another exemplary embodiment for sealingthe oxygen carrying conduit 104 to the skin of the thoracic wall at thesite of the ventilation bypass. In this exemplary embodiment, balloonflanges 400 may be utilized to create the seal. The balloon flanges 400may be attached to the oxygen carrying conduit 104 such that in thedeflated state, the oxygen carrying conduit 104 and one of the balloonflanges passes through the ventilation bypass anastomosis. The balloonflanges 400 are spaced apart a sufficient distance such that the balloonflanges remain on opposite sides of the thoracic wall. When inflated,the balloons expand and form a fluid tight seal by sandwiching thethoracic wall. Once again, this exemplary embodiment allows for easyremoval of the oxygen carrying conduit 104.

[0062]FIG. 5 illustrates yet another exemplary embodiment for sealingthe oxygen carrying conduit 104 to the skin of the thoracic wall at thesite of the ventilation bypass. In this exemplary embodiment, a singleballoon flange 500 is utilized in combination with a fixed flange 502.The balloon flange 500 is connected to the oxygen carrying conduit 104in the same manner as described above. In this exemplary embodiment, theballoon flange 500, when inflated, forms the fluid tight seal. The fixedflange 502, which is maintained against the skin of the thoracic wall,provides the structural support against which the balloon exertspressure to form the seal.

[0063] If an individual has difficulty exhaling and requires additionaloxygen, collateral ventilation bypass may be combined with direct oxygentherapy. FIG. 6 illustrates an exemplary embodiment of a collateralventilation bypass/direct oxygen therapy system 600. The system 600comprises an oxygen source 602, an oxygen carrying conduit 604 havingtwo branches 606 and 608, and a control valve 610. The oxygen source 602and oxygen carrying conduit 604 may comprise components similar to theabove-described exemplary embodiment illustrated in FIG. 1. In thisexemplary embodiment, when the individual inhales, the valve 610 is openand oxygen flows into the lung 612 and into the bronchial tube 614. Inan alternate exemplary embodiment, the branch 608 may be connected tothe trachea 616. Accordingly, during inhalation oxygen flows to thediseased site in the lung or lungs and to other parts of the lungthrough the normal bronchial passages. During exhalation, the valve 610is closed so that no oxygen is delivered and air in the diseased portionof the lung may flow from the lung 612, through one branch 606 and intothe second branch 608 and finally into the bronchial tube 616. In thismanner, stale air is removed and oxygen is directly delivered. Onceagain, as described above, the flow of oxygen and air is regulated bysimple pressure differentials.

[0064] The connection and sealing of the oxygen carrying conduit 604 andbranches 606, 608 to the lung 612 and bronchial tube 614 may be made ina manner similar to that described above.

[0065] The above-described long term oxygen therapy system may beutilized to effectively treat hypoxia caused by chronic obstructivepulmonary disease; however, other means may be desirable to treat otheraspects of the disease. As set forth above, emphysema is distinguishedas irreversible damage to lung tissue. The breakdown of lung tissueleads to the reduced ability for the lungs to recoil. The tissuebreakdown also leads to the loss of radial support of the nativeairways. Consequently, the loss of elastic recoil of the lung tissuecontributes to the inability for individuals with emphysema to exhalecompletely. The loss of radial support of the native airways also allowsa collapsing phenomenon to occur during the expiratory phase ofbreathing. This collapsing phenomenon also intensifies the inability forindividuals to exhale completely. As the inability to exhale increases,residual volume in the lungs also increases. This then causes the lungto establish in a hyperinflated state wherein an individual can onlytake short shallow breaths.

[0066] The collateral ventilation bypass trap system of the presentinvention utilizes the above-described collateral ventilation phenomenonto increase the expiratory flow from a diseased lung or lungs, therebytreating another aspect of chronic obstructive pulmonary disease.Essentially, the most collaterally ventilated area of the lung or lungsis determined utilizing the scanning techniques described above. Oncethis area or areas are located, a conduit or conduits are positioned ina passage or passages that access the outer pleural layer of thediseased lung or lungs. The conduit or conduits utilize the collateralventilation of the lung or lungs and allows the entrapped air to bypassthe native airways and be expelled to a containment system outside ofthe body.

[0067]FIG. 7 illustrates a first exemplary collateral ventilation bypasstrap system 700. The system 700 comprises a trap 702, an air carryingconduit 704 and a filter/one-way valve 706. The air carrying conduit 704creates a fluid communication between an individual's lung 708 and thetrap 702 through the filter/one-way valve 706. It is important to notethat although a single conduit 704 is illustrated, multiple conduits maybe utilized in each lung 708 if it is determined that there is more thanone area of high collateral ventilation.

[0068] The trap 702 may comprise any suitable device for collectingdischarge from the individual's lung or lungs 708. Essentially, the trap702 is simply a containment vessel for temporarily storing dischargefrom the lungs, for example, mucous and other fluids that may accumulatein the lungs. The trap 702 may comprise any suitable shape and may beformed from any suitable metallic or non-metallic materials. Preferably,the trap 702 should be formed from a lightweight, non-corrosivematerial. In addition, the trap 702 should be designed in such a manneras to allow for effective and efficient cleaning. In one exemplaryembodiment, the trap 702 may comprise disposable liners that may beremoved when the trap 702 is full. The trap 702 may be formed from atransparent material or comprise an indicator window so that it may beeasily determined when the trap 702 should be emptied or cleaned. Alightweight trap 702 increases the patient's mobility.

[0069] The filter/one-way valve 706 may be attached to the trap 702 byany suitable means, including threaded fittings or compression typefittings commonly utilized in compressor connections. The filter/one-wayvalve 706 serves a number of functions. The filter/one-way valve 706allows the air from the individual's lung or lungs 708 to exit the trap702 while maintaining the fluid discharge and solid particulate matterin the trap 702. This filter/one-way valve 706 would essentiallymaintain the pressure in the trap 702 below that of the pressure insidethe individual's lung or lungs 708 so that the flow of air from thelungs 708 to the trap 702 is maintained in this one direction. Thefilter portion of the filter/one-way valve 706 may be designed tocapture particulate matter of a particular size which is suspended inthe air, but allows the clean air to pass therethrough and be vented tothe ambient environment. The filter portion may also be designed in sucha manner as to reduce the moisture content of the exhaled air.

[0070] The air carrying conduit 704 connects the trap 702 to the lung orlungs 708 of the patient through the filter/one-way valve 706. The aircarrying conduit 704 may comprise any suitable biocompatible tubinghaving a resistance to the gases contained in air. The air carryingconduit 704 comprises tubing having an inside diameter in the range fromabout {fraction (1/16)} inch to about ½ inch, and more preferably fromabout ⅛ inch to about ¼ inch. The filter/one-way valve 706 may compriseany suitable valve which allows air to flow from the lung or lungs 708through the air carrying conduit 704, but not from the trap 702 back tothe lungs 708. For example, a simple check valve may be utilized. Theair carrying conduit 704 may be connected to the filter/one-way valve706 by any suitable means. Preferably, a quick release mechanism isutilized so that the trap may be easily removed for maintenance. Asillustrated in FIG. 7, the air carrying conduit 704 passes through thelung 708 at the site determined to have the highest degree of collateralventilation. If more than one site is determined, multiple air carryingconduits 704 may be utilized. The connection of multiple air carryingconduits 704 to the filter/one-way valve 706 may be accomplished by anysuitable means, including an octopus device similar to that utilized inscuba diving regulators.

[0071] The air carrying conduit 704 is preferably able to withstand andresist collapsing once in place. Since air will travel through theconduit 704, if the conduit is crushed and unable to recover, theeffectiveness of the system is diminished. Accordingly, a crushrecoverable material may be incorporated into the air carrying conduit704 in order to make it crush recoverable. Any number of suitablematerials may be utilized. For example, Nitinol incorporated into theconduit 704 will give the conduit collapse resistance and collapserecovery properties.

[0072] Expandable features at the end of the conduit 704 may be used toaid in maintaining contact and sealing the conduit 704 to the lungpleura. Nitinol incorporated into the conduit 704 will provide theability to deliver the conduit 704 in a compressed state and thendeployed in an expanded state to secure it in place. Shoulders at theend of the conduit may also provide a mechanical stop for insertion andan area for an adhesive/sealant to join as described in detailsubsequently.

[0073] In order for the exemplary collateral ventilation bypass trapsystem 700 to function, an airtight seal is preferably maintained wherethe air carrying conduit 704 passes through the thoracic cavity andlungs 708. This seal is maintained in order to sustain theinflation/functionality of the lungs. If the seal is breached, air canenter the cavity and cause the lungs to collapse. One exemplary methodfor creating the seal comprises forming adhesions between the visceralpleura of the lung and the inner wall of the thoracic cavity. This maybe achieved using either chemical methods, including irritants such asDoxycycline and/or Bleomycin, surgical methods, including pleurectomy orthorascopic talc pleurodesis, or radiotherapy methods, includingradioactive gold or external radiation. All of these methods are knownin the relevant art for creating pleurodesis. In another alternateexemplary embodiment, a sealed joint between the air carrying conduit704 and the outer pleural layer includes using various glues to helpwith the adhesion/sealing of the air carrying conduit 704. Currently,Focal Inc. markets a sealant available under the tradename Focal/Seal-Lwhich is indicated for use on a lung for sealing purposes. Focal/Seal-Lis activated by light in order to cure the sealant. Another sealavailable under the tradename Thorex, which is manufactured by SurgicalSealants Inc., is currently conducting a clinical trial for lung sealingindications. Thorex is a two-part sealant that has a set curing timeafter the two parts are mixed.

[0074] The creation of the opening in the chest cavity may beaccomplished in a number of ways. For example, the procedure may beaccomplished using an open chest procedure, aternotomy or thoracotomy.Alternately, the procedure may be accomplished using a laproscopictechnique, which is less invasive. Regardless of the procedure utilized,the seal should be established while the lung is at least partiallyinflated in order to maintain a solid adhesive surface. The opening maythen be made after the joint has been adequately created between theconduit component and the lung pleural surface. The opening should beadequate in cross-sectional area in order to provide sufficientdecompression of the hyperinflated lung. This opening, as stated above,may be created using a number of different techniques such as cutting,piercing, dilating, blunt dissection, radio frequency energy, ultrasonicenergy, microwave energy, or cryoblative energy.

[0075] The air carrying conduit 704 may be sealed to the skin at thesite by any of the means and methods described above with respect to theoxygen carrying conduit 704 and illustrated in FIGS. 2 through 5.

[0076] In operation, when an individual exhales, the pressure in thelungs is greater than the pressure in the trap 702. Accordingly, the airin the highly collaterilized areas of the lung will travel through theair carrying conduit 704 to the trap 702. This operation will allow theindividual to more easily and completely exhale.

[0077]FIG. 8 illustrates another exemplary collateral ventilation bypasssystem 800. In this exemplary embodiment, the trachea is utilized toremove trapped air rather than the native airways. As illustrated, afirst conduit 802 extends from the patient's trachea 804, or otherproximal airways, including the bronchus, to a position external of thepatient's body. A second conduit 806 is connected to the first conduit802 via a fitting 808 and passes through the thoracic wall 810 andpasses through the lung 812 at the site determined to have the highestdegree of collateral ventilation. If more than one site is determined tohave a high degree of collateral ventilation, multiple conduits may beutilized. In operation, when the patient exhales, the pressure in thelungs is greater than the pressure in the trachea 804; accordingly, theair in the highly collaterilized areas of the lung will travel throughthe first and second conduits 802, 806 to the trachea 804 and out of thepatient's nose and mouth with the normally exhaled air.

[0078] The first and second conduits 802, 806 may comprise any suitablebiocompatible tubing having a resistance to the various gases and otherconstituents contained in inhaled and exhaled air. As in previouslydescribed embodiments, the first and second conduits 802, 806 comprisetubing having an inside diameter in the range from about {fraction(1/16)} inch to about ½ inch, and more preferably from about ⅛ inch toabout ¼ inch.

[0079] The connection of the first conduit 802 to the trachea 804 maycomprise any suitable airtight seal. For example, a fluid communicationbetween the trachea 804 and the first conduit 802 may be established ina manner identical to that established for a tracheotomy. In addition,as stated above, in order for the collateral ventilation bypass system800 to function, an airtight seal is preferably maintained where thesecond conduit 806 passes through the thoracic wall 810 and into thelungs 812. An exemplary method for creating this airtight seal comprisesforming adhesions between the visceral pleura of the lung and theparietal pleura. This may be achieved using either chemical methods,including irritants, surgical methods, including pleurectomy orthorascopic talc pleurodesis, or radiotherapy methods, includingradioactive gold or external radiation.

[0080] The creation of the opening in the thoracic wall may beaccomplished in a number of ways. For example, the procedure may beaccomplished using an open chest procedure, aternotomy or thoracotomy.Alternately, the procedure may be accomplished using a laproscopictechnique, which is less invasive. Regardless of the procedure utilized,the seal should be established while the lung is at least partiallyinflated in order to maintain a solid adhesive surface. The opening maythen be made after the joint has been adequately created between theconduit component and the lung pleural surface. The opening should beadequate in cross-sectional area in order to provide sufficientdecompression of the hyperinflated lung. This opening, as stated above,may be created using a number of different techniques such as cutting,piercing, dilating, blunt dissection, radio frequency energy, ultrasonicenergy, microwave energy, or cryoblative energy.

[0081] The conduits 802, 806 may be sealed to the skin at the sites byany known methods, including those described above with respect to FIGS.2 through 5. The connection of the extrathoracic component, conduit 806,may comprise a drug, chemical, agent, or other means for preventing orsubstantially reducing the risk of infection.

[0082] The fitting 808 connecting the first and second conduits 802, 806may comprise any suitable device for creating an airtight seal. Thefitting 808 may comprise any type of threaded or non-threaded union,compression fittings similar to compressor type fittings or any othersuitable device for establishing an airtight seal and providing forquick release between the two ends of the fitting 808. This type ofdesign would allow easy access for periodic maintenance of the system800, for example, cleaning the conduits 802, 806. Since the fitting 808is external to the body, access to the inner body component of thesystem 800 would be easier. Essentially, access of the system 800 fromoutside the body would allow for maintenance and diagnosis/observationof the system 800 without subjecting the patient to additional stressand risk. It would also be less time consuming for the doctor.

[0083]FIG. 9 illustrates an alternate exemplary embodiment of theexemplary collateral ventilation bypass system 800 described above. Inthis exemplary embodiment, the system 900 comprises an externallypositioned access port 908. As illustrated, a conduit 902 extends fromthe patient's trachea 904, or other proximal airways, including thebronchus, through a suitable passageway internal to the patient's bodyand then passes through the lung 912 at the site determined to have thehighest degree of collateral ventilation. As set forth above, if morethan one site is determined to have a high degree of collateralventilation, multiple conduits may be utilized. At the desired locationwithin the body, the access port 908 may be placed in-line with theconduit 902 such that at least a portion of the access port 908 isaccessible outside of the body. Essentially, the access port 908 shouldallow the patient or a doctor to open the port and access the system 900within the patient's body for maintenance and diagnosis/observation ofthe system 900 as described above.

[0084] The access port 908 may comprise any suitable device forproviding an airtight seal when closed and easy access to the conduit902 when open. The access port 908 may comprise various valvearrangements and connectors for connecting other components which may beutilized for various functions. For example, oxygen may be supplieddirectly to the patient's lungs 912 if needed. In this instance, a valvemay be needed to prevent the oxygen from bypassing the lungs 912 and gostraight to the trachea 904.

[0085] All the remaining components may be the same as described above.In addition, all seals may be accomplished as described above.

[0086] In yet another alternate exemplary embodiment, the extrathoracicaccess port 908, illustrated in FIG. 9, may be positioned just under theskin so that it is accessible percutaneously. Essentially, the accessport would not truly be extrathoracic, but rather just located under theskin and accessible extrathoracically. In this exemplary embodimentaccess would not be as easily accessible; however, the access pointwould remain more discrete than the previously described exemplaryembodiments. FIG. 10 illustrates this exemplary embodiment.

[0087] As illustrated in FIG. 10, the collateral ventilation bypasssystem 1000 comprises a conduit 1002 that extends from the patient'strachea 1004, or other proximal airways, including the bronchus, througha suitable passageway internal to the patient's body and then passesthrough the lung 1012 at the site determined to have the highest degreeof collateral ventilation. As set forth above, if more than one site isdetermined to have a high degree of collateral ventilation, multipleconduits may be utilized. At the desired location within the body, aninternal access port 1008 may be placed in-line with the conduit 1002.The access port 1008 may comprise any suitable device that allows accessvia percutaneous means. All remaining components may be the same asdescribed above. In addition, all seals may be accomplished as describedabove.

[0088] It is important to note that in each of the above-describedexemplary embodiments, additional components may be added that functionto prevent flow from the trachea end of the conduit to the lung. Forexample, one or more valves may be incorporated throughout the systemsto prevent mucus and other substances from entering or re-entering thelung. The main function of the system is to allow exhalation. In theory,patients with emphysema have increased resistance to expiration and notinhalation. Any suitable valves may be utilized, for example, one-waycheck valves.

[0089]FIG. 11 illustrates yet another alternate exemplary collateralventilation bypass system 1100. In this exemplary embodiment, like theexemplary embodiments illustrated in FIGS. 8-10, the trachea or otherproximal airways, including the bronchus, is utilized to remove airtrapped in the lung or lungs. As illustrated, a conduit 1102 extendsfrom the patient's bronchus 1104 and passes directly into the lung 1106at the site determined to have the highest degree of collateralventilation. If more than one site is determined to have a high degreeof collateral ventilation, multiple conduits may be utilized. Inoperation, when the patient exhales, the pressure in the lungs isgreater than the pressure in the bronchus 1104; accordingly, the air inthe highly collateralized area or areas of the lung will travel throughthe conduit 1102 to the bronchus 1104, into the trachea 1108 and out ofthe patient's nose and mouth, not shown, with the normally exhaled air.

[0090] The conduit 1102 in this exemplary embodiment does not leave thepatient's body. The conduit 1102 may comprise any suitable biocompatibletubing having a resistance to the various gases and other constituentscontained in inhaled and exhaled air. As in previously describedexemplary embodiments, the conduit 1102 comprises tubing having aninside diameter in the range from about {fraction (1/16)} inch to about½ inch, and more preferably in the range from about ⅛ inch to about ¼inch.

[0091] The conduit 1102 preferably is able to withstand and resistcollapsing. Since air will travel through the conduit 1102, if theconduit 1102 is crushed and is unable to recover, the effectiveness ofthe procedure may be substantially reduced. Therefore, various materialsmay be incorporated into the conduit 1102 to make it crush recoverable.For example, materials exhibiting super elastic or shape memoryproperties or characteristics may be utilized. Nitinol incorporated intothe conduit 1102 will give the component collapse resistance andcollapse recovery properties. The conduit 1102 may comprise a polymericcoating over a suitably arranged nitinol base structure. The polymericcoating or cover layer may be formed from any suitable polymericmaterials, including polytetrafluoroethylene, silicone andpolyurethanes.

[0092] The conduit 1102 may also comprise modified ends. For example,expandable features at each end may be utilized to maintain contact andsealing between the conduit 1102 and/or the bronchus 1104, the trachea1108, and the lung 1106 pleura. Once again, nitinol or other similarproperty materials may be incorporated into the conduit 1102 and thusprovide the conduit 1102 to be delivered in a smaller diametercompressed state and then deployed in a larger diameter expanded stateto help secure it in place. Alternately, shoulders at each end of theconduit 1102 may also provide a mechanical stop for insertion and anarea for an adhesive/sealant to join.

[0093] The conduit 1102 may be introduced into the body of the patientin a number of ways. In one exemplary embodiment, the conduit 1102 maybe introduced utilizing an open-chest procedure, for example, asternotomy or thoracotomy. In al alternate exemplary embodiment, theconduit 1102 may be introduced utilizing a laproscopic technique to makethe procedure less invasive. It is important to note that the conduit1102 may be incorporated into the opening creating device. If theconduit 1102 is incorporated with the opening creating device, theconduit 1102 may be inserted and established in the same step as theopening creation.

[0094] As stated in the above-described exemplary embodiments, in orderfor the collateral ventilation bypass system 1100 to function, anairtight seal is preferably made between the conduit 1102 and the outerpleural layer of the lung 1106. This seal is maintained in order tosustain the inflation/functionality of the lungs. If the seal isbreached, air can enter the pleural space and cause the lungs tocollapse. One method for creating the seal involves pleuroderis orforming adhesions between the visceral pleura of the lung and the innerwall of the thoracic cavity as briefly described above and in moredetail subsequently. In another alternate exemplary embodiment, a sealedjoint between the conduit 1102 and the outer pleural layer includesusing various glues to help with the adhesion/sealing of the conduit1102 as described above. Regardless of the procedure utilized, the sealshould be established while the lung is at least partially inflated inorder to maintain a solid adhesive surface. The opening may then be madeafter the joint has been adequately created between the conduit 1102 andthe lung pleural surface. The opening should be adequate incross-sectional area in order to provide sufficient decompression of thehyperinflated lung.

[0095] The connection of the conduit 1102 to the trachea or bronchus1104 should also be an airtight seal. For example, fluid communicationbetween the bronchus 1104 and the conduit 1102 may be established in amanner identical to that established for a tracheotomy.

[0096] The conduit 1102 may be positioned at any suitable locationwithin the patient's body. Preferably, the conduit 1102 is positionedsuch that it will not affect the patient's ability to function normally.

[0097] It is important to note that in the above-described exemplaryembodiment, additional components may be added that function to preventflow from the bronchus to the lung. For example, one or more valves orfilters may be incorporated into the conduit to prevent mucus and othersubstances from entering or re-entering the lung. The main function ofthe collateral ventilation bypass system is to allow exhalation. Intheory, patients with emphysema have increased resistance to expirationand not inspiration. Any suitable valves may be utilized, for example,one-way check valves.

[0098] As described above, pulmonary emphysema leads to the breakdown oflung tissue, which in turn leads to the reduced ability of the lungs torecoil and the loss of radial support of the airways. Consequently, theloss of elastic recoil of the lung tissue contributes to the inabilityof individuals to exhale completely. The loss of radial support of theairways also allows a collapsing phenomenon to occur during theexpiratory phase of breathing. This collapsing phenomenon alsointensifies the inability for individuals to exhale completely. As theinability to exhale completely increases, residual volume in the lungsalso increases. This then causes the lung or lungs to establish in ahyperinflated state where an individual can only take short shallowbreaths. Essentially, air is not effectively expelled and stale airaccumulates in the lungs. Once the stale air accumulates in the lungs,the individual is deprived of oxygen.

[0099] Lung volume reduction surgery is an extremely traumatic procedurethat involves removing part or parts of the lung or lungs. By removingthe portion of the lung or lungs which is hyperinflated, pulmonaryfunction may improve due to a number of mechanisms, including enhancedelastic recoil, correction of ventilation/perfusion mismatch andimproved efficiency of respiratory work. Essentially, as theemphysematous tissue volume is reduced, the healthier tissue is betterventilated. However, lung volume reduction surgery possesses a number ofpotential risks as described in more detail subsequently.

[0100] The collateral ventilation bypass trap system 700, illustrated inFIG. 7, and the collateral ventilation bypass system 800, illustrated inFIG. 8, utilize the collateral ventilation phenomenon to allow the airentrapped in the lung or lungs to bypass the native airways and beexpelled either to a containment vessel or to the ambient environment.However, in an alternate exemplary embodiment, a device, which workssimilarly to collateral ventilation bypass and provides resultscommensurate with lung volume reduction surgery, is disclosed herein.Essentially, in this exemplary embodiment, the invention is directed toa device and associated method for assisting pulmonary decompression. Inother words, the present invention is directed to pulmonarydecompression assist device and method that would provide a means forthe removal of trapped air in the emphysematous lung and the maintenanceof the emphysematous area compressed to a smaller volume, with theresult being that healthier lung tissue will have more volume in thethoracic cavity to ventilate. The effects of this device may be similarto that of lung volume reduction surgery.

[0101] The exemplary pulmonary decompression assist device of thepresent invention may be strategically positioned in the body of apatient such that it is in fluid communication with the patient's lungor lungs and the external environment. The device would allow air to beexhaled out from the lung or lungs through the native airways whileassisting in removing trapped air in the hyperinflated portion of thelung or lungs. Lung volume reduction surgery is an extremely invasiveand traumatic procedure that in a substantially high number of casescauses the patients undergoing the procedure to become excluded frombeing a candidate for lung transplantation. The device of the presentinvention provides for a minimally invasive procedure for causing thelung volume to reduce similarly to lung volume reduction surgery whileallowing the patient to remain a viable candidate for lungtransplantation.

[0102] The exemplary pulmonary decompression device may utilize anynumber of known techniques for creating a sufficient pressuredifferential between the inside of the lung or lungs and an areaexternal of the lung or lungs to allow the trapped air to exit the lungor lungs. The device may comprise any suitable device such as pumps orfans or any other means to create the pressure differential. If thecollateral airflow and areas of emphysema are situated so that air mayreinflate that area, the device may be configured to continuously drawair from the lung or lungs to maintain a smaller lung volume of theemphysematous tissue. The device may be left in the patient's bodyindefinitely in order to maintain the compression of the emphysematoustissue in the lung or lungs. In addition, in order to maintain thecleanliness of the device and the safety of the patient, the device maybe constructed as a disposable device and be replaced at variousintervals. In addition, portions of the device that are easilyaccessible may be made disposable. Alternately, the device may beconstructed for easy removal, easy cleaning and easy replacement.

[0103] Referring to FIG. 12, there is illustrated an exemplary pulmonarydecompression device 1200 in accordance with the present invention. Asdescribed herein, there is generally an optimal location to penetratethe outer pleura of the lung to access the most collaterally ventilatedarea or areas of the lung and a variety of techniques to locate the areaor areas. Once the desired location is determined, the decompressiondevice 1200 may be inserted into the lung 1202. On insertion andplacement of the decompression device 1200 into the lung 1202, it isparticularly advantageous to establish an airtight seal of the parietaland visceral pleurae. If a proper airtight seal is not created betweenthe decompression device, parietal and visceral pleurae, then apneumothorax may occur.

[0104] It is important to note that one or more devices may be utilizedin each lung to remove trapped air from highly collateralized areas.Alternately, a single device with multiple conduits may be utilized. Asillustrated in FIG. 12, the decompression device 1200 is placed in thelung 1202 in the area of highest collateral ventilation 1204. In oneexemplary embodiment, only a first section 1206 of the decompressiondevice 1200 is positioned within the lung 1202 while a second section1208 of the decompression device 1200 is secured external to the lung1202. The sealing of the device 1200 may be made in accordance with anyof the devices and methodologies described herein.

[0105] At least a portion of the second section 1208 is external to thepatient's body. The portion of the second section 1208 that is externalto the patient's body may exit the body at any suitable location. In oneexemplary embodiment, the portion of the second section 1208 exists thebody through the chest and thus may be sealed in accordance with any ofthe devices and methodologies described herein.

[0106] The first section 1206 may comprise any suitable biocompatiblematerial configured to facilitate the flow of air from the lung 1202.For example, the first section 1206 may comprise a conduit similar insize, material and construction as the other conduits described herein.The second section 1208 may be connected to the first section 1206 byany suitable means, including threaded unions or compression typefittings. The second section 1208 comprises a housing for an apparatusthat draws air from the hyperinflated portion of the lung 1204 throughthe first section 1206 and directs it out of the patient's body. Theapparatus may include any suitable device for creating a pressuredifferential between the inside and outside of the lung 1202 such thatair will easily flow from the lung 1202. The apparatus may include aminiature pump or fan. The miniature pump or fan may be powered by anysuitable means, including batteries or rechargeable batteries. In theabove-described exemplary embodiment, the miniature pump or fan and itspower supply may be housed completely in the housing. In other alternateexemplary embodiments, one or more of the pump/fan or power supply maybe located remotely from the second section 1208. For example, thesecond section 1208 may simply comprise a second conduit removablyconnected on one end to the first conduit and on a second end to theapparatus that draws air from the diseased section of the lung 1204.

[0107] In the exemplary embodiment illustrated in FIG. 12, the apparatusthat draws air from the diseased section of the lung 1204 and itsassociated power supply are housed within the second section 1208. Thisdesign provides the most freedom for the patient. Various knownminiature vacuum pumps or fans may be used to continuously draw air fromthe diseased section of the lung 1204, thereby reducing theemphysematous tissue volume and allowing the healthier tissue toventilate better. The miniature fan/pump and associated power supply maybe separate components or a single component. These miniature devicesmay comprise microelectromechanical systems or MEMS, or any othersuitable device for drawing air from one location and venting it to asecond location. The decompression device 1200 should be designed to beeasily maintained. For example, the second section 1208 may be made suchthat it can be removed, the power supply recharged and the othercomponents cleaned and then replaced. Alternately, the second section1208 may simply be disposable.

[0108] The power supply may comprise any suitable means for supplyingpower continuously for extended periods of time. The power supply maycomprise batteries, rechargeable batteries, piezoelectric devices thatgenerate electrical power from mechanical strain or any other suitabledevice. In addition, other than a fan or pump for creating a vacuum,some type of switching elements may be utilized for creating a slightpressure differential.

[0109] Accordingly, rather than a resection of the lung tissue, thedecompression device removes trapped air from the emphysematous sectionof the lung and maintains the emphysematous section in a compressedstate or smaller volume, thereby allowing the healthier lung tissue morevolume in the thoracic cavity to ventilate. FIG. 13a illustrates thedecompression device 1200 removing air from the hyperinflated portion1302 of the lung 1300. As illustrated, in this lung, the hyperinflatedor emphysematous portion 1302 of the lung 1300 is larger than thehealthy section or portion 1304 of the lung 1300. As the device 1300continues to remove the accumulated or trapped air, the volume of thehyperinflated portion 1302 of the lung 1300 shrinks, thereby allowingthe healthier portion 1304 more room to fully ventilate, therebyincreasing in volume as illustrated in FIG. 13b.

[0110] In an alternate exemplary embodiment, a more passive device maybe utilized for reducing the size of the lung. A lung reduction devicemay be strategically positioned about the body of a patient and accessthe patient's lung or lungs. The device would allow air to be expelledfrom the lung or lungs while preventing air from re-enteringtherethrough. Essentially, the device would comprise at least onecomponent that accesses the outer pleural layer of the emphysematousportion or portions of the patient's lung or lungs. This at least onecomponent will utilize the collateral ventilation of the lung or lungsand allow the entrapped air in the emphysematous portion or portions ofthe lung or lungs to bypass the native airways and expel through to theoutside of the body through a second component. The second componentincludes a feature that allows air to flow from the lung or lungs to theambient environment, but not from the ambient environment back into thelung or lungs. If the collateral airflow and areas of emphysema aresituated so that air cannot reinflate these portions of the lung orlungs, then a size reduction of that area of the lung should occur.

[0111] Referring to FIGS. 14a and 14 b, there is illustrated anexemplary lung reduction device 1400 in accordance with the presentinvention. As described herein, there is generally an optimal locationto penetrate the outer pleura of the lung to access the mostcollaterally ventilated area or areas of the lung or lungs and a varietyof techniques to locate these areas. Once the desired location orlocations are determined, the lung reduction device 1400 may be insertedinto the lung 1402. The insertion or introduction of the device 1400 maybe accomplished utilizing a number of minimally invasive techniques, forexample, percutaneously or endoscopically, thereby substantiallyreducing the risk to the patient and trauma to the lung or lungs. It isimportant to note that all of the systems and devices described hereinare preferably implanted utilizing minimally invasive techniques. Oninsertion and placement of the lung reduction device 1400 into the lung1402, it is particularly advantageous to establish an airtight seal ofthe parietal and visceral pleurae utilizing any of the techniques,devices and processes described herein. If an airtight seal is notestablished between the lung reduction device 1400, parietal andvisceral pleurae, then a pneumothorax may occur.

[0112] It is important to note that one or more lung reduction devicesmay be utilized in each lung to remove trapped air from highlycollateralized areas. Alternately, a single lung reduction device influid communication, through conduits or other similar means, withmultiple locations may be utilized. For case of explanation, a singledevice and single diseased portion is described and illustrated. Onceagain, referring to FIGS. 14a and 14 b, the lung reduction device 1400is implanted in the lung 1402 in the area of highest collateralventilation 1404. In the exemplary embodiment illustrated, a firstsection 1406 of the lung reduction device 1400 is positioned within theinner volume of the lung 1402 while a second section 1408 of the lungreduction device 1400 is secured to the patient's body external to thelung 1402. The first section 1406 of the device 1400 accesses theparenchyma of the lung 1402. The parenchyma are the cells in tissuesthat are concerned with function rather than structure. In other words,the first section 1406 accesses the alveoli of the lung 1402. Theattainment of an airtight seal of the lung reduction device 1400 may bemade in accordance with any of the devices and methodologies describedherein.

[0113] At least a portion of the second section 1408 is external to thepatient's body. The portion of the second section 1408 that is externalto the patient's body may exit or extend from the body at any suitablelocation. Preferably, the portion of the second section 1408 exits at alocation that proves to be of minimum burden to the patient and allowsfor easy access for maintenance, repair or replacement. In one exemplaryembodiment, the portion of the second section 1408 exits the bodythrough the chest and thus may be sealed in accordance with any of thedevices and methodologies described herein.

[0114] The first section 1406 may comprise any suitable device forfacilitating the flow of air from the lung 1402. For example, the firstsection 1406 may comprise a conduit similar in size, material andconstruction or any of the other conduits described herein. The secondsection 1408 may be connected to the first section 1406 by any suitablemeans, including threaded connectors, unions or compression typefittings.

[0115] The second section 1408 may comprise any suitable means forallowing one-way airflow. In one exemplary embodiment, the secondsection 1408 comprises a housing 1410 and a one-way valve 1412. Thehousing 1410 may be formed from any suitable biocompatible material. Aportion of the housing 1410 houses the one-way valve 1412 while anotherportion of the housing 1410 forms the portion that is external to thebody. The one-way valve 1412 may comprise any suitable pressure actuatedvalve, which allows air to flow from one lung 1402 to the ambientenvironment. The one-way valve 1412 may comprise a check valve, a reedvalve, needle valves, flapper check valves or any other suitable device.In preferred embodiments, the one-way valve 1412 requires only a slightpressure differential to open and allow air flow from the lung 1402 tothe ambient or external environment, but does not allow air flow backinto the lung 1402 even under substantial reverse pressure.

[0116] In operation, when the person inhales, the volume of the thoraciccavity increases by the contraction of the diaphragm and thus the volumeof the lungs also increases. As the volume of the lungs increase, thepressure of the air in the lungs falls slightly below the pressure ofthe air external to the body and thus air flows through the respiratorypassageways into the lungs until the pressure equalizes. When the personexhales, the diaphragm is relaxed, the volume of the thoracic cavitydecreases, which in turn decreases the volume of the lungs. As thevolume of the lungs decrease, the pressure of the air in the lungs risesslightly above the pressure of the air external to the body.Accordingly, as a result of this slight pressure differential, the airin the alveoli is expelled through the respiratory passageways until thepressure equalizes. However, in the diseased area 1404 of the lung 1402,normal exhalation does not work for the reasons described herein andthus the increased pressure in the lung 1402 opens the one-way valve1412 and air flows from the diseased portion 1404 through the firstsection 1406, through the one-way valve 1412 and out of the body.

[0117] The lung reduction device 1400 may be left in the lungindefinitely to maintain the compression of the emphysematous tissuelung 1400 as described above with respect to the decompression device.In order to maintain cleanliness and safety, the lung reduction device1400 or at least portions thereof may be made disposable and thus bereplaced at regular intervals or when needed. As the lung reductiondevice 1400 continues to allow the trapped air to exit the lung 1402,the volume of the hyperinflated or diseased portion 1404 of the lung1400 shrinks, thereby allowing the healthier portion of the lung 1400more room to fully ventilate, thereby increasing in volume asillustrated in FIG. 14b.

[0118] The lung reduction device 1400 may be left in the body until thearea of the compressed emphysematous tissue has permanently compressed,atelectasis. At this point, the lung reduction device 1400 maypotentially be removed safely. If healing of the insertion site of thereduction device 1400 has occurred, the fistula created may bepermanently sealed.

[0119] In the above-described exemplary apparatus and procedure forincreasing expiratory flow from a diseased lung using the phenomenon ofcollateral ventilation, there will be an optimal location to penetratethe outer pleura of the lung to access the most collaterally ventilatedarea or areas of the lung. In addition, in the above-described exemplarypulmonary decompression assist device, there is an optimal location fordecompressing the hyperinflated lung or lungs. As described above, thereare a variety of techniques to locate the most collaterally ventilatedarea or areas of the lungs. Since a device or component of the apparatusfunctions to allow the air entrapped in the lung to bypass the nativeairways and be expelled outside of the body, it is particularlyadvantageous to provide an airtight seal of the parietal (thoracic wall)and visceral (lung) pleurae. If a proper airtight seal is not createdbetween the device, parietal and visceral pleurae, then a pneumothorax(collapsed lung) may occur. Essentially, in any circumstance where thelung is punctured and a device inserted, an airtight seal shouldpreferably be maintained.

[0120] One way to achieve an airtight seal is through pleurodesis, i.e.an obliteration of the pleural space. There are a number of pleurodesismethods, including chemical, surgical and radiological. In chemicalpleurodesis, an agent such as tetracycline, doxycycline, bleomycin ornitrogen mustard may be utilized. In surgical pleurodesis, a pleurectomyor a thorascopic talc procedure may be performed. In radiologicalprocedures, radioactive gold or external radiation may be utilized. Inthe present invention, chemical pleurodesis is utilized.

[0121] Exemplary devices and methods for delivering a chemical(s) oragent(s) in a localized manner for ensuring a proper airtight seal ofthe above-described apparatus is described below. The chemical(s),agent(s) and/or compound(s) are used to create a pleurodesis between theparietal and visceral pleura so that a component of the apparatus maypenetrate through the particular area and not result in a pneumothorax.There are a number of chemical(s), agent(s) and/or compound(s) that maybe utilized to create a pleurodesis in the pleural space. Thechemical(s), agent(s) and/or compound(s) include talc, tetracycline,doxycycline, bleomycin and minocycline.

[0122] In one exemplary embodiment, a modified drug delivery cathetermay be utilized to deliver chemical(s), agent(s) and/or compound(s) to alocalized area for creating a pleurodesis in that area. In thisexemplary embodiment, the pleurodesis is formed and then the conduit704, as illustrated in FIG. 7, is positioned in the lung 708 through thearea of the pleurodesis. The drug delivery catheter provides a minimallyinvasive means for creating a localized pleurodesis. Referring to FIG.15, there is illustrated an exemplary embodiment of a drug deliverycatheter that may be utilized in accordance with the present invention.Any number of drug delivery catheters may be utilized. In addition, thedistal tip of the catheter may comprise any suitable size, shape orconfiguration thereby enabling the formation of a pleurodesis having anysize, shape or configuration.

[0123] As illustrated in FIG. 15, the catheter 1500 is inserted into thepatient such that the distal end 1502 is positioned in the pleural space1504 between the thoracic wall 1508 and the lung 1506. In theillustrated exemplary embodiment, the distal end 1502 of the catheter1500 comprises a substantially circular shape that would allow thechemical(s), agent(s) and/or compound(s) to be released towards theinner diameter of the substantially circular shape as indicated byarrows 1510. The distal end 1502 of the catheter 1500 comprising aplurality of holes or openings 1512 through which the chemical(s),agent(s) and/or compound(s) are released. As stated above, the distalend 1502 may comprise any suitable size, shape or configuration. Oncethe chemical(s), agent(s) and/or compound(s) are delivered, the catheter1500 may be removed to allow for implantation of the conduit 704 (FIG.7). Alternately, the catheter 1500 may be utilized to facilitatedelivery of the conduit 704.

[0124] The distal end or tip 1502 of the catheter 1500 should preferablymaintain its desired size, shape and/or configuration once deployed inthe pleural space. This may be accomplished in a number of ways. Forexample, the material forming the distal end 1502 of the catheter 1500may be selected such that it has a certain degree of flexibility forinsertion of the catheter 800 and a certain degree of shape memory suchthat it resumes its original or programmed shape once deployed. Anynumber of biocompatible polymers with these properties may be utilized.In an alternate embodiment, another material may be utilized. Forexample, a metallic material having shape memory characteristics may beintegrated into the distal end 1502 of the catheter 1500. This metallicmaterial may include nitinol or stainless steel. In addition, themetallic material may be radiopaque or comprise radiopaque markers. Byhaving a radiopaque material or radiopaque markers, the catheter 1500may be viewed under x-ray fluoroscopy and aid in determining when thecatheter 1500 is at the location of the highest collateral ventilation.

[0125] In another alternate exemplary embodiment, a local drug deliverydevice may be utilized to deliver the pleurodesis chemical(s), agent(s)and/or compound(s). In this exemplary embodiment, the pleurodesis isformed and then the conduit 704, as illustrated in FIG. 7, is positionedin the lung 708 through the pleurodesis. In this exemplary embodiment,chemical(s), agent(s) and/or compound(s) may be affixed to animplantable medical device. The medical device is then implanted in thepleural cavity at a particular site and the chemical(s), agent(s) and/orcompound(s) are released therefrom to form or create the pleurodesis.

[0126] Any of the above-described chemical(s), agent(s) and/orcompound(s) may be affixed to the medical device. The chemical(s),agent(s) and/or compound(s) may be affixed to the medical device in anysuitable manner. For example, the chemical(s), agent(s) and/orcompound(s) may be coated on the device utilizing any number of wellknown techniques including, spin coating, spraying or dipping, they maybe incorporated into a polymeric matrix that is affixed to the surfaceof the medical device, they may be impregnated into the outer surface ofthe medical device, they may be incorporated into holes or chambers inthe medical device, they may be coated onto the surface of the medicaldevice and then coated with a polymeric layer that acts as a diffusionbarrier for controlled release of the chemical(s), agent(s) and/orcompound(s), they may be incorporated directly into the material formingthe medical device, or any combination of the above-describedtechniques. In another alternate embodiment, the medical device may beformed from a biodegradable material which elutes the chemical(s),agent(s) and/or compound(s) as the device degrades.

[0127] The implantable medical device may comprise any suitable size,shape and/or configuration, and may be formed using any suitablebiocompatible material. FIG. 16 illustrates one exemplary embodiment ofan implantable medical device 1600. In this embodiment, the implantablemedical device 1600 comprises a substantially cylindrical disk 1600. Thedisk 1600 is positioned in the pleural space 1602 between the thoracicwall 1604 and the lung 1606. Once in position, the disk 1600 elutes orotherwise releases the chemical(s), agent(s) and/or compound(s) thatform the pleurodesis. The release rate may be precisely controlled byusing any of the various techniques described above, for example, apolymeric diffusion barrier. Also, as stated above, the disk 1600 may beformed from a biodegradable material that elutes the chemical(s),agent(s) and/or compound(s) as the disk 1600 itself disintegrates ordissolves. Depending upon the material utilized in the construction ofthe disk 1600, a non-biodegradable disk 1200 may or may not requireremoval from the pleural cavity 1602 once the pleurodesis is formed. Forexample, it may be desirable that the disk 1600 is a permanent implantthat becomes integral with the pleurodesis.

[0128] As described in the previous exemplary embodiment, the disk 1600may comprise a radiopaque marker or be formed from a radiopaquematerial. The radiopaque marker or material allows the disk 1600 to beseen under fluoroscopy and then positioned accurately.

[0129] In yet another alternate exemplary embodiment, the fluidcharacteristics of the chemical(s), agent(s) and/or compound(s) may bealtered. For example, the chemical(s), agent(s) and/or compound(s) maybe made more viscous. With a more viscous chemical agent and/orcompound, there would be less chance of the chemical, agent and/orcompound moving from the desired location in the pleural space. Thechemical(s), agent(s) and/or compound(s) may also comprise radiopaqueconstituents. Making the chemical(s), agent(s) and/or compoundsradiopaque would allow the confirmation of the location of thechemical(s), agent(s) and/or compound(s) with regard to the optimallocation of collateral ventilation.

[0130] The chemical(s), agent(s) and/or compound(s) as modified abovemay be utilized in conjunction with standard chemical pleurodesisdevices and processes or in conjunction with the exemplary embodimentsset forth above.

[0131] Although shown and described is what is believed to be the mostpractical and preferred embodiments, it is apparent that departures fromspecific designs and methods described and shown will suggest themselvesto those skilled in the art and may be used without departing from thespirit and scope of the invention. The present invention is notrestricted to the particular constructions described and illustrated,but should be constructed to cohere with all modifications that may fallwithin the scope of the appended claims.

What is claimed is:
 1. An intra-thoracic collateral ventilation bypasssystem comprising: at least one conduit having first and second ends,the first end being in fluid communication with an airway in proximityto a trachea of a patient and the second end being in fluidcommunication with the inner volume of a lung of a patient at apredetermined site; a first sealing device for establishing an airtightseal between the conduit and the airway; and a second sealing device forestablishing an airtight seal between the conduit and the lung.
 2. Amethod for decompressing a hyperinflated portion of a lung of a patientcomprising: determining a site of hyperinflation in a patient's lung;and bypassing non-patent airways utilizing a device in communicationwith a hyperinflated portion of a patient's lung and an airway proximatea patient's trachea.